Security is one of the most important concept, we use different techniques and methods to secure the things that have importance in our life. Likewise the documents in the organizations are important they may have the critical information in it, which can be use to accomplish your mission and goals. They need to be secured from unauthorized access. In our ever changing technology based world, it is imperative to have control over all of your documents physically.
The solution for this is the Electronic Document Control Systems. It allows you not only to store the documents but also to manage, organize and secured the documents. To be called the secured document control system a system must be compliant to some of the following standards.
1) HIPAA
2) FDA
3) 21 CFR part 11
4) GLP
5) QSR
6) ISO
These are some of the standard that an ideal electronic document control system must have.
These all standards are the basic need and a system must follow the rules and guidelines specified.
HIPAA is an abbreviation of Health Insurance Portability and Accountability ACT. It is a set of strict rules and regulations regarding privacy of patient for an organization that provide health care services. It’s regulations apply to any organization that collects, stores, processes, retains, or has any level of access to an individual’s’ health information. Violations of the HIPAA rules can lead to very severe financial penalties, criminal charges and even jail time.
Following are some rules of HIPAA that DocControl follows.
1. Data Backups and Disaster Recovery:-
DocControl databases are backed up daily and securely transferred to multiple off-site locations for disaster recovery purposes.
2. Audit Trials:-
DocControl provides secure and time stamped audit trial that captures all document processes.
3. Accessibility:-
DocControl has three access levels: Administrators, Users, and Viewers and every one has been provided with different user id and password to protect the data.
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services. The most important title of FDA is 21 CFR part 11. It defines the criteria under which electronic records and electronic signatures are considered to be honest, reliable and equivalent to paper records.
Let us have a look on some of the rules and regulations of 21 CFR Part 11
1. The system must be able to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection.
In DocControl, the user can download and print all of the files uploaded to the system, with complete audit trail. The system is also capable of exporting the digital data in a report format.
2. Protection of records to enable their accurate and ready retrieval throughout the records retention period.The uploaded files in the DocControl are accessible until they retired. At which point, the files and their history are available to Administrators.
3. Limiting system access to authorized individuals .To access the DocControl system a user must have an account with unique user name and password.
4. Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
The workflow for checking out and in a document is limited to the originator. Only one person can checkout a file at a time.
GLP [Good Laboratory Practice] contains a set of standards that provides a framework in which laboratory studies are planned, recorded, reported and archived. QSR [Quality System Regulation] is a FDA standard FDA has identified the essential elements for a quality system.
DocControl is a next generation document control and management system, in which the security of the documents is at the highest priority. Electronic Signature, Awesome Revision Control and secure audit trail are some of the features of DocControl system. It is fully compliant to all the above described standards and their sections.